Plain English Summary

Background and study aimsLow back pain (LBP) is the leading cause of disability worldwide. Over 70% of people will suffer with LBP in their lifetime, and the chance of having the most serious forms of LBP increases with age. It is associated with loss of mobility and falls in older people leading to loss of independence and frailty, however, this is the time in life when GPs and patients are least likely to prioritise treatment for LBP. In later life people are much more likely to have other health conditions which they think are more important than LBP. Some older people just grin and bear the pain, accepting it as part of ageing. Although there is a large body of research in LBP, this has focused almost exclusively on younger people. Hence there is little guidance appropriate to older people. Lumbar spinal stenosis is a common back condition in older adults where the spinal cord is compressed due to narrowing of the spinal canal. This leads to a range of symptoms including pain, tingling, numbness or heaviness spreading from the back into one or both legs, together known as neurogenic claudication. Neurogenic claudication is a common symptom of lumbar spinal stenosis (narrowing of the spine leading to compression of the spinal cord), a leading cause of LBP in the aging population. Neurogenic claudication affects a person’s ability to walk and stand which impacts on their ability to remain independent. There is little research to help us know what type of physiotherapy is best for people with neurogenic claudication. The aim of this study is to compare the effectiveness of two different approaches to physiotherapy which have been designed to help older adults with neurogenic claudication to stay mobile and remain independent.

Who can participate?Adults aged 65 years or over who live at home and report symptoms of neurogenic claudication.

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group take part in a 12-week group physiotherapy programme. This involves weekly hour-and-a-half long sessions of exercises and group discussions about ways to manage symptoms and be more physically active. Those in the second group receive an individual session with a physiotherapist in which they are provided with information about exercises and how best to manage their symptoms. These participants can receive two follow up sessions if required. Participants in both groups complete a number of questionnaires and physical assessments at the start of the study and again 6, 12 and 24 months later in order to find out if their symptoms have improved.

What are the possible benefits and risks of participating?Participants may benefit from an improvement to their back and leg symptoms because of the advice, information and exercises given to them by the physiotherapist. There is a risk of muscle soreness after completing some of the exercises however this is normal and the physiotherapist will provide advice on how to manage this. Some participants may feel uncomfortable answering certain questions about their health during the study, but they will be advised that they are not obliged to answer any questions they are not comfortable with.

Where is the study run from?1. The Royal Orthopaedic Hospital, Birmingham (UK)2. Nuffield Orthopaedic Centre, Oxford (UK)

When is the study starting and how long is it expected to run for?April 2015 to April 2020

Who is funding the study?National Institute for Health Research (UK)

Who is the main contact?Professor Sallie Lamb sarah.lamb@ndorms.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Angela Garrett

ORCID ID

Contact details

Centre for Rehabilitation Research in Oxford Botnar Research Centre University of Oxford Windmill Road Headington Oxford OX3 7LD United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

BOOST RCT

Study hypothesis

The aim of this study is to evaluate the clinical and cost-effectiveness of a group physiotherapy programme for people with neurogenic claudication due to spinal stenosis compared to best practice advice.

Ethics approval

London - Brent Research Ethics Committee, 10/03/2016, ref: 16/LO/0349

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Neurogenic claudication, Spinal stenosis

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants take part in a 12-week group physiotherapy programme comprising of a progressing exercise programme underpinned by cognitive behavioural strategies to promote engagement and adherence with the programme. Each class lasts for 1.5 hours and will involve exercises and group discussions about ways to manage symptoms and be more physically active.

Control group: Participants receive one individual session to provide information about exercise and self-management with two optional follow up sessions if required.

After treatment, participants will be invited to two follow-up appointments with the researcher (6 and 12 months after they join the study). They will also receive a questionnaire in the post 2 years after joining the study which we will ask them to complete and return to the BOOST Trial Team.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Secondary outcome measures

1. Back pain and leg symptoms is measured using the Swiss Spinal Stenosis Questionnaire (symptom subscale) at baseline, 6, 12 and 24 months2. Physical activity is measured using Rapid Assessment Disuse Index (modified) at baseline, 6, 12 and 24 months3. Mobility is measured using a 6 minute walk test and short physical performance battery at baseline 6, 12 and 24 months4. Frailty, fatigue and sleep is measured using the Tilberg Frailty Index at baseline, 6, 12 and 24 months5. Falls and falls related injuries are measured using self-report at baseline, 6, 12 and 24 months, and Short Physical Performance Battery (SPPB) at baseline.6. Disability and health related quality of life is measured using the EQ5D-5L at baseline, 6, 12 and 24 months7. Perceived change is measured using the Global rating of perceived change scale at 6, 12 and 24 months 8. Self-efficacy is measured using Self-efficacy recovery and maintenance related to performing home exercises andSingle item from the Modified Gait Self-Efficacy Scale at baseline, 6, 12 and 24 months and the Exercise self-efficacy scale (short version) at baseline.9. Fear avoidance is measured using the Fear avoidance beliefs questionnaire at baseline,6, 12 and 24 months10. Habit is measured using Index of habit (short version) at 6, 12 and 24 months11. Satisfaction with attempts to increase physical activity is measured using 5 point scale questionnaire at 6, 12 months12. Satisfaction with treatment is measured using 5 point scale questionnaire at 6, 12 months13. Adherence to home exercise programme is measured through self-reporting at 6, 12 months14. Sagittal alignment of the spine is measured using occiput to wall measure at baseline,6, 12 months and MRI scan parameters at baseline.15. Health resource use and treatment costs is measured using self-report and structured interview at 6, 12 months.16. Other pain measured by Nordic pain questionnaire at baseline and 24 months.

Overall trial start date

01/04/2015

Overall trial end date

29/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 65 years and over2. Registered with a primary care practice3. Living in the community, including sheltered or supported housing4. Willing and able to give informed consent for participation in the trial 5. Reports symptoms consistent with neurogenic claudication

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A minimum of 402 participants will be recruited into the RCT.

Participant exclusion criteria

1. Living in a residential care or nursing home2. Has a terminal condition with a life expectancy of less than 6 months3. Any substantial health or social concern that, in the opinion of the patient’s general practitioner, would place the patient at increased risk or inability to participate including known inability to provide informed consent e.g. Dementia4. Unable to walk 3 meters without the help of another person5. On a surgical waiting list6. Presents with cauda equina syndrome or signs of serious pathology requiring immediate referral for investigations 7. Cognitive impairment (defined as an Abbreviated Mental Test score of 6 or less)8. Registered blind9. Unable to follow verbal instructions which would make participation in the exercise group impractical including severe hearing impairment not corrected by a hearing aid or inability to follow simple safety instructions (eg English comprehension)

Sponsor type

Website

Funders

Funder type

Funder name

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of the trial will be reported first to trial collaborators. The main report will be drafted by the research team and subject to external peer review prior to publication. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Findings from the research will be disseminated at conferences and via a dedicated website. A summary of the study outcomes will also be available to study participants on relevant websites and directly circulated by way of study newsletters.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 01/04/2021 to 29/08/2020
2. The total target enrolment has been updated from 402 to 438
3. The recruitment end date was changed from 30/09/2018 to 29/08/2018
23/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/09/2018.
2. The overall trial end date was changed from 01/04/2020 to 01/04/2021.
3. The intention to publish date was changed from 31/12/2020 to 31/12/2021.
22/12/2017: The following changes were made:
1. Angela Garrett replaced Frances Darton as the primary study contact.
2. The recruitment start date was changed from 01/02/2016 to 25/07/2016.
3. The recruitment end date was changed from 01/08/2017 to 30/06/2018.